Phase I Trial to Evaluate VLP Peanut in Healthy and Peanut Allergic Subjects

NCT05476497 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: VLP-Peanut101
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 10

Brief Summary

This phase I clinical trial is designed to evaluate the safety and tolerability of VLP Peanut in healthy subjects and in subjects with peanut allergy (PA). This clinical trial will evaluate the immunotoxicity profile of VLP Peanut in healthy subjects and assess the immunotoxicity profile and the degree of reactogenicity (allergenicity) in subjects with PA. This clinical trial will also explore preliminary proof of efficacy of VLP Peanut in subjects with PA.

Conditions

Peanut Allergy

Outcome Measures

Primary Outcomes (2)

• Number and severity of Adverse Events (AEs) (including local and systemic AEs).

  Group A1: 18 weeks; Part B: 64 weeks (Part B). Group A2: 3 days.

• Number of subjects discontinuing prematurely from treatment due to AEs

  Group A1: 11 weeks Part B: 15 weeks

Secondary Outcomes (53)

• Incidence of fatigue (tiredness)

  Group A1: 14 weeks Part B: 16 weeks

• Frequency of fatigue (tiredness)

  Group A1: 14 weeks Part B: 16 weeks

• Incidence of headache

  Group A1: 14 weeks Part B: 16 weeks

• Frequency of headache

  Group A1: 14 weeks Part B: 16 weeks

• Incidence of muscle pain

  Group A1: 14 weeks Part B: 16 weeks

Study Arms (3)

Part A - Group A1

EXPERIMENTAL

4 parallel cohorts (1-4) of adult healthy subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut.

Biological: VLP Peanut

Part A - Group A2

EXPERIMENTAL

Adult peanut allergic subjects, will undergo skin prick tests with ascending concentrations of VLP Peanut.

Biological: VLP Peanut

Part B - Cohorts 1-4

EXPERIMENTAL

4 parallel cohorts (1-4) of peanut allergic subjects. Each cohort will receive 6 ascending subcutaneous administrations of VLP Peanut.

Biological: VLP Peanut; Biological: Placebo

Interventions

VLP Peanut BIOLOGICAL

solution for subcutaneous administration

Part A - Group A1; Part B - Cohorts 1-4

Placebo BIOLOGICAL

solution for subcutaneous administration

Part B - Cohorts 1-4

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Capable of giving signed informed consent.
• Subject who has a signed and dated Informed Consent Form (ICF).
• Subject must be 18 to 50 years inclusive, at the time of signing the ICF.
• Male or female.
• Female subjects who are not of childbearing potential (or females of childbearing potential who agree to comply with the contraceptive requirements of the clinical trial protocol).
• Good general health, as determined by the Investigator.
• A positive SPT to histamine.
• Healthy subjects (non-atopic) with no clinically significant co-morbidity (including broncho-reactive airway disease like asthma, current allergic rhinitis, etc.).
• Subjects with no history of allergy or intolerance to peanut or any other food and who consume peanuts with no effect.
• Subjects with lack of sensitivity to peanut allergen confirmed by SPT using whole peanut extract.
• Peanut specific immunoglobulin E (IgE) \<0.35 kU/L.
• Ara h 2 specific IgE \<0.35 kU/L.
• Subjects with negative basophil activation test (BAT).
• Clinical history of physician diagnosed PA.
• Peanut allergen sensitivity confirmed by SPT and IgE.

You may not qualify if:

• Pregnant or lactating subject.
• Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
• Subjects with atopic dermatitis with \>25% skin surface involvement.
• For subjects with PA, presence of severe, poorly controlled or uncontrolled asthma.
• History of severe or life-threatening anaphylactic reactions to peanut resulting in neurological compromise or requiring mechanical ventilation.
• History of severe or life-threatening anaphylactic reactions to foods (excluding peanuts), insect venom, exercise, drugs, or idiopathic causes, resulting in neurological compromise or requiring mechanical ventilation or deemed severe as per Investigator assessment.
• Unable to receive epinephrine therapy or at greater risk of developing adverse reactions after epinephrine administration as assessed by the site Investigator.
• Clinical history of drug or alcohol abuse, which, in the Investigator's opinion, could interfere with the subject's ability to participate in the clinical trial.
• Participation in a clinical research trial with any investigational drug/placebo within 3 months of screening (Visit 1) or concomitantly with this clinical trial.
• Personal, financial or other dependent relationship (e.g., employee or immediate relative) with the clinical trial site, Sponsor, Sponsor's representative, or another individual who has access to the clinical trial protocol.
• Vulnerable subjects or those in judicial or governmental detention, detainment or imprisonment in a public institution.

Sponsors & Collaborators

• Allergy Therapeutics: lead

Study Sites (10)

University of Arizona

Tucson, Arizona, 85724, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63141, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Trio Clinical Trials, LLC.

Houston, Texas, 77008, United States

Location

University of Wisconsin School of Medicine and Public Health Asthma, Allergy, and Pulmonary Clinical Research

Madison, Wisconsin, 53792-9988, United States

Location

Related Publications (1)

• Layhadi JA, Starchenka S, De Kam PJ, Palmer E, Patel N, Keane ST, Hikmawati P, Drazdauskaite G, Wu LYD, Filipaviciute P, Parkin RV, Oluwayi K, Rusyn O, Skinner MA, Heath MD, Hewings SJ, Kramer MF, Turner P, Shamji MH. Ara h 2-expressing cucumber mosaic virus-like particle (VLP Peanut) induces in vitro tolerogenic cellular responses in peanut-allergic individuals. J Allergy Clin Immunol. 2025 Jan;155(1):153-165. doi: 10.1016/j.jaci.2024.08.010.

  PMID: 39756833 DERIVED

MeSH Terms

Conditions

Peanut Hypersensitivity

Condition Hierarchy (Ancestors)

Nut and Peanut Hypersensitivity; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Pieter-Jan De Kam, PhD

  Allergy Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part A is open label. Part B is double blind, placebo controlled
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Two part clinical trial: Part A- Open-label with two groups (A1 and A2): i) A1 (Healthy Subjects): subcutaneous (SC) dosing with ascending concentrations of VLP Peanut. ii) A2 (peanut allergic subjects): skin prick test (SPT) performed with ascending concentrations of VLP Peanut. Part B - double-blind, placebo-controlled part that will enroll Peanut Allergic Subjects: subcutaneous (SC) dosing with ascending concentrations of VLP Peanut.

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 27, 2022
• Study Start: October 17, 2022
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

US (10)